LumiraDx Submits Dual FDA Medical Device Application for Covid-19 Test
2023年7月1日 - 4:26AM
Dow Jones News
By Sabela Ojea
LumiraDx said Friday that it submitted a dual U.S. Food and Drug
Administration medical devices application for the clearance of its
Covid-19 ultra test.
The diagnostic technology company said its 510(k) dual
submission aims to receive approval for the commercial distribution
at point of care of the LumiraDx platform, which enables
lab-comparable performance across a broad menu of diagnostic
assays, in conjunction with its Covid-19 test and Covid-19 Ag
Quality control swab kit.
The company had received several emergency use authorizations
for its Covid-19 tests during the pandemic.
At 14:50 E.T., shares rose 2.7%, to 44 cents.
Write to Sabela Ojea at sabela.ojea@wsj.com
(END) Dow Jones Newswires
June 30, 2023 15:11 ET (19:11 GMT)
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